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Pharmaceutical and Medical Translation Services

Pharmaceutical and Medical Translation Services

High-quality translations with short turnaround times in the medical field, where expertise is required, through the combination of people and technology.

The life sciences industry, often referred to as a representative industry of the 21st century, is becoming increasingly advanced as it integrates with various related fields alongside ongoing research.
In particular, in the core areas of pharmaceuticals and medical care, the demand for translation services for various documents is rising in tandem with the rapid advancement of the global economy.
We will continue to provide translation solutions utilizing systems such as Trados and XChecker to enhance efficiency and accuracy in response to the increasing volume of medical and pharmaceutical documents.

Fields of Expertise

Basic Research and Non-Clinical
IB (Investigator's Brochure), Protocol (Study Plan), Various Test Reports (Efficacy Pharmacology Tests, Pharmacokinetics Tests, Toxicity Tests, Safety Tests, etc.), SOP, etc.
Clinical Development and Approval Application
IB (Investigator's Brochure), Protocol (Clinical Trial Protocol), ICF (Informed Consent Form), CSR (Clinical Study Report), CRF (Case Report Form), CIOMS, eCTD compliant, eTMF compliant
Medical Device
Approval application documents, PMDA inquiry items, FDA inspection materials, operation manuals, instruction manuals, UI (user interface), catalogs, attached documents, specification sheets
Manufacturing Development & Quality Assurance
CTD, PMDA inquiry items, FDA inspection materials, application attachment documents, PMS (post-marketing survey) materials, re-examination and re-evaluation application materials, adverse event report materials, real-world data materials
Manufacturing, Sales & Marketing
Comprehensive product catalog, attached documents, white papers, news releases, web pages, videos, promotional content, PMS (post-marketing survey) materials
Laws, Regulations, Standards
Laws and regulations of each country, various guidelines such as ICH and GCP, CE marking application documents, ISO acquisition application documents, SOP
Academic
Academic papers, compliance with submission guidelines, creation of paper abstracts, conference presentation materials, summarization of lecture content, treatment guidelines
Education Related
Educational content for MR, training content for medical device operation, educational content for medical accident scenes
Others
Medical and pharmaceutical journal articles, specialized books, questionnaires, medical accident materials, litigation-related documents, proposals, contracts, patent specifications, annual reports

Language-Specific Achievements

English → Japanese
Cancer clinical trial drug protocols, cardiovascular clinical trial drug CSRs, obstetrics and gynecology clinical trial drug CSRs, PMDA inquiries for otolaryngology medical devices, FDA materials for cardiovascular medical devices, cancer treatment drug CIOMS, antibody drug CTD 2.3, biopharmaceutical CTD 2.3, academic papers in the gastrointestinal field, creation of abstracts for dialysis-related papers, user manuals for surgical medical devices, user SOPs for analytical instruments, instruction manuals for ventilators, otolaryngology medical device manuals
Japanese → English
CSR for respiratory cancer clinical trial drugs, IB for gastrointestinal cancer clinical trial drugs, ICF for gynecological field, protocols for cancer clinical trial drugs, treatment guidelines for respiratory field, PMDA inquiry items for obstetrics and gynecology, drug introduction materials for cancer clinical trial drugs, submitted papers in psychosomatic medicine, submitted papers in cell biology, academic papers in cardiovascular field, reports on drug pricing in pharmaceutical economics, medical-related notifications issued by the Ministry of Health, Labour and Welfare
Multilingual
Overview reports of clinical trials in the ophthalmology field, manuals for medical devices in the ophthalmology field, and manuals and catalogs for examination devices in the cardiology field.

Case Studies

Translation of Informed Consent Documents for Foreign-affiliated CROs (Japanese to English)
Translation Volume: 43,000 characters
Delivery Time / Work Period: 8 Business Days
Utilizing Trados, work done by two translators
Foreign-affiliated CRO CIOMS Narrative English-Japanese Translation
Translations occur daily and are delivered within 1 business day (within 24 hours)
Dedicated system (Project Manager, Translator, Reviewer) for timely support
The English text has been created by different doctors, and due to variations in style and English proficiency, standardization will be performed before the translation work.
The updates are done using Trados, allowing for efficient translation work through differential translation.
Presentation materials introducing drugs (cancer treatment drugs) for doctors and pharmacists for a foreign pharmaceutical company - Japanese to English translation
Translation Volume: 63 PPT pages, 43,000 characters
Delivery Time / Work Period: 7 business days *Including DTP
Translate using Trados while considering readability for presentation materials.
Domestic Pharmaceutical Company Protocol (Clinical Trial Implementation Plan) Overview English-Japanese Translation
Translation Volume: 10,000 characters
Delivery Time / Work Period: 6 Business Days
To prioritize quality, we propose a process where native experts in the field perform proofreading.

 

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